Diagnostic Autonomic denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for diagnostic autonomic are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why Cigna Denied Autonomic Diagnostic Testing as Not FDA-Approved

This denial reason is unusual for diagnostic procedures because FDA approval applies to drugs and devices, not to diagnostic test protocols per se. If Cigna applied this denial to autonomic testing, it may mean one of several things: (1) a specific device used in the testing (such as a sudomotor testing device or a tilt-table monitoring system) is not FDA-cleared for the claimed indication; (2) the test was performed under a research protocol; or (3) the denial language was applied in error and the actual basis is "investigational" or "experimental." Read the denial letter and EOB carefully to identify which CPT codes were denied and the precise language used. If the denial says "not FDA-approved" but means "investigational," the appeal strategy differs — see the experimental/investigational guidance.

## Why This Denial Is Appealable

Established autonomic function tests — including tilt-table testing and QSART — are performed using FDA-cleared or FDA-exempt devices and are recognized by major professional societies including the American Academy of Neurology and the American Autonomic Society. If the testing was performed with standard, cleared equipment for an established clinical indication, the "not FDA-approved" characterization is likely factually incorrect. Challenging the factual basis of the denial is itself grounds for reversal.

## Federal Appeal Framework

Under ACA Section 2719 and ERISA Section 503, you have the right to a full-and-fair internal review and then independent external review. The external review process is particularly powerful here: an independent reviewer can assess whether Cigna's characterization of the test as unapproved is factually and clinically supported. File the internal appeal within the deadline on the denial letter (typically 180 days), then request external review within four months of a final internal denial.

## Documentation to Gather

• Device information: The manufacturer and FDA clearance number (510(k) or PMA) for the testing equipment used. The performing laboratory or facility can provide this.
• Professional society recognition: A brief from the ordering or performing physician citing the relevant professional society guideline (e.g., American Academy of Neurology or American Autonomic Society) that recognizes the test as standard of care for the indication — without asserting specific numeric thresholds.
• Denial specifics: Exact CPT codes denied and Cigna's stated rationale — to determine whether "not FDA-approved" is the correct basis or a misclassification.
• Clinical necessity letter: Prescriber letter establishing why the study was ordered and how it fits standard diagnostic practice.

## Criteria-Mapping Structure

| Cigna's Stated Denial Basis | Counter-Evidence | |---|---| | Device or test "not FDA-approved" | FDA clearance number for equipment used; professional society guideline recognition | | Research/investigational characterization | Peer-reviewed clinical use; CPT code active status; Medicare coverage determination if applicable |